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cleanroom operations

 

  Develop Standard Operating Procedures Using IEST Recommended Practices

 

Learn how to write an effective standard operating procedure incorporating the fundamentals of IEST recommended practices.  Effective SOP's will create a robust contamination control program in your cleanroom operations.  Be prepared to write your compnay's standard operating procedure for the selection of cleanroom garments and gowning in your cleanrooms, a standard operating procedure for behavior in your cleanroom and a standard operating procedure for testing and monitoring your cleanroom.

Course outline     Who should attend?     Course materials     Instructor     Next date and location

 



Course outline

  1. Best practices for SOP development
    1. Create a SOP that directs:
      1. How to write a SOP
      2. Review a SOP
      3. Approve a SOP
      4. Distribute a SOP
      5. Review and revise all SOP’s
  2. Harmonization with industry standards
    1. ISO 14644-5 Cleanrooms and Associated Controlled Environments – Operations
    2. FDA c GMP’s
  3. Development of Process Map of Cleanroom Operations
    1. Linear product flow
    2. Linear personnel flow
  4. SOP Content
    1. Header
      1. Company name
      2. Supersedes date
      3. Effective date
      4. Procedure number
      5. Procedure name
    2. Approval signatures and date
    3. Purpose
    4. Scope
    5. Definitions
    6. Applicable reference documents
    7. Procedure
      1. Specifications
      2. Materials and equipment
      3. Methods
      4. Diagrams, flow charts, Visuals
      5. Records and forms NOTE:  Must link form to SOP.
    8. Corrective Action
    9. Preventive Action
    10. Change History
    11. Confidentiality and document control
  5. Compliance
    1. Changing SOP’s
      1. Describe areas of SOP to be changed
      2. Rationale for the change – what and why
      3. Validation data
      4. Temporary or permanent change
      5. Approval signatures and dates
    2. Training to SOP’s
      1. Review written SOP
      2. Written test to check for comprehension
      3. Performance of SOP
      4. Periodic review and assessment of efficacy and validity of SOP
    3. Continuous training and positive reinforcement of procedures and policies
    4. Continuous audits for compliance
    5. Continuous improvement through six sigma initiatives, etc.
    6. Continuous documentation of all activities.
  6. Workshop
  7. Create individual SOP’s on company template to:
    1. IEST-RP-CC003 – Cleanroom Garments and Gowning
    2. IEST-RP-CC027 – Cleanroom procedures, practices and policies
    3. IEST-RP-CC006 – Testing cleanrooms and environmental monitoring

 

Who should attend?

Information coming soon.

 

Course materials

  • Copy of PowerPoint presentation in course binder
  • Certificate of attendance for completion of CEUs

Continuing Education Units: .6 CEUs

Instructor

 Jan Eudy

 


Next dates and locations

Thursday, November 14, 2019
During the IEST Fall Conference
Rosemont, Illinois

Click here for more information and to register.

Corporate Sponsors

Thank you to our the support from our Corporate Sponsors

Strategic Level

Gold Level